Alva Health, a medtech startup based in Connecticut, is developing a wristband that can detect the signs of stroke and promptly alert the wearer and/or healthcare staff. The technology is intended for those at high risk of stroke, such as stroke survivors and those diagnosed with transient ischemic attack.
Strokes cause a huge level of patient morbidity every year, with many suffering debilitating symptoms that are life changing. Early diagnosis and prompt treatment are very important, but in many cases the early symptoms of a stroke are subtle and are easily missed. These issues have inspired this startup to develop a stroke monitor for high-risk patients.
The system consists of a wrist band that looks for signs of paralysis on one side of the body, a hallmark of stroke. The company was recently announced as the winner of the MedTech Innovator 2021 $350,000 global grand prize for their innovation.
See a video below that explains the wearable developed by Alva Health.
Medgadget had the opportunity to speak with Sandra Saldana, CEO & Co-Founder of Alva Health about the firm’s technology.
Medgadget: How is stroke currently diagnosed/monitored, and why is this suboptimal?
Sandra Saldana: IV tissue plasminogen activator (tPA) has been an FDA approved therapy since 1995, yet only 5–10% of eligible patients receive this therapy due to delays in initiating the emergency response. Currently, stroke diagnosis can only be performed by a clinical team in the hospital or through telemedicine delivered on a mobile stroke unit. The diagnostic workup consists of a physical exam and neurological assessment, combined with brain imaging including a CT scan, MRI scan, carotid ultrasound, cerebral angiogram, and/or echocardiogram. The purpose of diagnosis is to rule out other conditions and to assess whether the patient is having an ischemic or a hemorrhagic stroke, which informs the type of treatment that is administered. However, in order for a patient to undergo this battery of tests and ultimately receive treatment, they must first recognize their symptoms as stroke symptoms, call 911, and arrive in an emergency room that is equipped to treat stroke patients. Because most people are not trained to recognize stroke symptoms quickly, and stroke symptoms can be subtle, patients do not immediately recognize the symptoms as stroke, and as a result they delay in seeking medical attention.
Medgadget: Please give us an overview of the importance of early diagnosis and treatment for stroke patients.
Sandra Saldana: It has been well documented that timely arrival in the emergency room after stroke symptom onset is directly associated with better outcomes for tPA treatment and endovascular therapy, specifically 4.5 hours and 8 hours, respectively. Early diagnosis and early treatment can prevent long term disability and save lives. It can mean the difference between living independently and needing assistance to perform the most basic functions. However, despite massive public health campaigns, identifying symptoms of stroke and activating emergency response systems has remained a major challenge over the years.
Medgadget: What inspired you to develop the technology inside the ALVA wristband? How did the idea come about?
Sandra Saldana: Alva Health’s mission is to develop a wearable medical grade solution to effectively monitor ischemic stroke and to allow for the initiation of emergency response in a timely manner. Once deployed, our solution will dramatically improve stroke emergency response and increase the number of patients receiving IV tPA and other reperfusion therapies in the acute setting. The idea came about from the personal experience of one of our founders, Dr. Kevin Sheth, a practicing stroke neurologist and faculty at the Yale School of Medicine, after he observed that stroke symptom recognition and delayed emergency response was a persistent problem that has seen very little improvement over the years. We were inspired to develop this technology after doing substantial customer discovery interviews with stroke neurologists, nurses, stroke survivors, caregivers, payers, and many other stakeholders along the stroke patient’s journey. After countless conversations, we were convinced that there is a significant clinical unmet need for people living with high risk of stroke and no marketed solutions available to monitor stroke symptoms outside of a hospital setting.
Medgadget: How do you envisage this wearable working? What are the signs of stroke that a wearable could monitor?
Sandra Saldana: We monitor stroke onset through wrist-worn wearables, a mobile app, and cloud-based analysis using machine learning algorithms. The solution monitors the onset of paralysis on only one side of the body that is one of the defining hallmarks of stroke, also known as hemiparesis. When the system detects stroke, the device notifies the user immediately. If there is no response from the user within two minutes, we will automatically connect them with trained personnel who will assess the user’s condition over the phone, call 911, and notify the user’s emergency contacts. Our initial users will consist of stroke survivors and people diagnosed with Transient Ischemic Attack, because both of these populations are known to have a high risk of recurrence within 90 days of the initial event. The wristbands will be worn around the clock throughout the entire high risk window.
Medgadget: What stage of the development process is the company at? Do you have a prototype device?
Sandra Saldana: We have developed a prototype device that will be deployed in the clinic with stroke survivors starting in the first half of 2022. Our next steps are to demonstrate proof of concept of continuous, long term monitoring of patients at home using our custom wearable devices, to gather additional clinical evidence for algorithm improvement, and to obtain usability data from our patients that we can incorporate into the design and development of the final product. We also plan to meet with the FDA in the first quarter of next year in order to outline our path to FDA clearance, and we are initiating conversations with payers to get an understanding of the evidence requirements for reimbursement decisions.
Medgadget: Congratulations on winning the 2021 Medtech Innovator Global Competition. How do you intend to spend the prize money?
Sandra Saldana: We are thrilled to have been recognized in this year’s MedTech Innovator global competition, and we look forward to accelerating our development timeline with the prize money. The funds will allow us to expand our team, accelerate the development of our cloud based software solution, and fund part of our clinical study in stroke survivors that is launching next year. The award is an important milestone in Alva Health’s journey that will enable us to accelerate our path toward bringing our long-term, continuous stroke monitoring solution to the millions of people living with high risk of stroke.
Link: Alva Health homepage..
